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The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.

The QMS Lidocaine Calibrator set is a six-level set (0, 0.5, 1.0, 10 µg/mL) of single analyte (lidocaine) calibrators.

The provided text describes a 510(k) premarket notification for the QMS Lidocaine Calibrators. It aims to demonstrate substantial equivalence to a predicate device, the Roche Preciset TDM II Calibrators. However, the document primarily focuses on comparing the intended use, components, and matrix of the new device with the predicate device, rather than presenting a detailed study that proves the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not available in the provided text. The document concludes with a claim of substantial equivalence based on the technological characteristics without detailing a performance study with specific acceptance criteria.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated or defined in the provided text. The document aims to demonstrate "substantial equivalence" to a predicate device, implying that its performance attributes should be comparable, but specific numerical acceptance criteria are not provided.
• Reported Device Performance: Not explicitly detailed in the provided text. The "Comparison of Technological Characteristics" section compares the design and intended use of the device to the predicate, not a performance evaluation against specific metrics.

2. Sample size used for the test set and the data provenance

• Not available. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not available. No test set or expert read ground truth is described.

4. Adjudication method for the test set

• Not applicable/Not available. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a calibrator for an assay, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available. The document focuses on the substance and composition of the calibrator, not on an algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not available. In the context of a calibrator, "ground truth" would typically refer to the known, accurate concentration of the analyte (lidocaine) in the calibrator solution. The document states the calibrators are "prepared by quantitative addition of lidocaine to human serum," implying that the concentration values are established by the manufacturing process.

8. The sample size for the training set

• Not applicable/Not available. This type of device (a calibrator) does not typically involve a "training set" in the context of machine learning or diagnostic algorithm development.

9. How the ground truth for the training set was established

• Not applicable/Not available. As above, no training set is described. The "ground truth" for the calibrator concentrations is established by the precise manufacturing formulation ("quantitative addition of lidocaine to human serum").

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